Real world feasibility of patient-based real time quality control (PBRTQC) using five analytes in a South African laboratory

Background: Patient-based real-time quality control (PBRTQC) identifies possible bias in methods by utilising shifts in trend of statistical measures in laboratory results. In this study we aimed to compare and optimize various PBRTQC procedures for serum alanine aminotransferase, albumin, calcium, ferritin and sodium.

Methods: In a bias simulation study, we added artificial bias to intervals of patient data and then evaluated the efficiency with which various PBRTQC procedures were able to detect this bias. PBRTQC procedures used included block size, moving statistic calculation, control limits as well as truncation limits. The number of patients till error detection, the false alarm rate as well as validation charts were utilised to select the optimal PBRTQC procedure for each analyte.

Results: The optimal PBRTQC procedures identified for each analyte were: ALT - MA T0 50 MaxMin; Albumin - MA T5 100 Perc; Calcium - MM T5 50 Perc; Ferritin - MA T0 100 MaxMin; and Sodium - MA T5 75 MaxMin. (T, Truncation limits; Control limits- MA, Moving Average, MM, Moving median; Perc, percentile) CONCLUSIONS: The use of large, real patient datasets allows for the reliable determination of laboratory-specific PBRTQC procedures. This study demonstrates that the moving average calculation excels in both normal and transformed analyte distributions. Whilst, the benefits of PBRTQC procedures are proven, the complex and time-consuming optimisation process may be a barrier to the rapid implementation in under-resourced countries.